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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR

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COOPERSURGICAL, INC. LEEP PRECISION GENERATOR Back to Search Results
Model Number LP-20-120
Device Problems Failure to Cut (2587); Output Problem (3005)
Patient Problem Insufficient Information (4580)
Event Date 01/10/2022
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc. Is currently investigating the reported condition.
 
Event Description
Won't cut or coag. Repair order 97659. Leep precision generator lp-20-120 e-complaint (b)(4).
 
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Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP PRECISION GENERATOR
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
Manufacturer Contact
michael marone
50 corporate drive
trumbull, CT 06611
4752651665
MDR Report Key13412665
MDR Text Key287115639
Report Number1216677-2022-00014
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963653
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Remedial Action Repair
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-20-120
Device Catalogue NumberLP-20-120
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/01/2022 Patient Sequence Number: 1
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